Type 1 Diabetes Clinical Trial
Official title:
Prevalence of Nocturnal Hypoglycemia in Children and Adolescents With Type 1 Diabetes on a Standard (TID) Insulin Regimen Using a Continuous Glucose Monitoring System (CGMS) - A Pilot Study
This study will help determine the frequency and magnitude of nocturnal hypoglycemia (low
blood sugar at night during sleep), in children with type 1 diabetes who are on a standard
insulin regimen, by using a Continuous Glucose Monitoring System (CGMS). Secondary objectives
include the establishment of a definition of nocturnal hypoglycemia for the CGMS and for the
calculation of sample size needed for future studies using CGMS. Nocturnal hypoglycemia (NH)
can be associated with significant morbidity including seizure and coma. The investigators
intend to use the CGMS in a future study investigating the use of a new insulin combination
aimed to decrease the frequency of NH in the pediatric population.
Thirty pediatric subjects with established type 1 diabetes mellitus will be asked to wear a
CGMS for 3 days. During this time the participants will be required to test and record
self-monitored blood glucose readings at designated time periods and if they have symptoms of
hypoglycemia. The comparison of these values with each other and with different previously
defined values of NH will allow for a clear definition of NH to be made. A survey has also
been designed to assess participant satisfaction with the CGMS.
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